MAUDE Adverse Event Report: PHILIPS /RESPIRONICS INC. DREAM STATION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Contamination /Decontamination Problem (2895); Noise, Audible (3273)

Patient Problem Sleep Dysfunction (2517)

Event Date 03/17/2023

Event Type  malfunction  

Event Description

My philips respironics cpap was under recall.After waiting almost a year for a replacement, philips sends me a refurbished, used unit which appears to be dirty and is extremely noisy.It makes a loud whirring noise when exhaling and inhaling while using the unit.I can hardly sleep due to the noise.And the fact that the device was used by another customer makes me feel gross to continue using it.With covid and other germs, how can they send used devices in which you could possibly be inhaling others' germs? i have severe sleep apnea and i need a cpap machine.I have already returned my old unit to philips.So i have no other choice but to continue to use this refurbished unit until i receive a new one.I have reached out to philips to send a brand new unit.Their response is that they cannot guarantee a new unit.Drink alcohol occasionally, one drink per week.Reference report mw5115912.

• Brand Name: DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS /RESPIRONICS INC.
• MDR Report Key: 16597449
• MDR Text Key: 311960547
• Report Number: MW5115913
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2023
• Patient Sequence Number: 1
• Treatment: CARVEDILOL; LOSARTAN; MULTIVITAMIN; SIMVISTATIN; ZYRTEC
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American